美罗培南治疗急性细菌性感染临床观察

目的：评价美罗培南治疗细菌性感染的安全性及有效性。方法：采用随机对照试验方法。试验组美罗培南500mg-1g，静脉点滴，每12h1次，对照组亚胺培南－西司他丁500mg/500mg-1g/1g，每12h1次，静脉点滴。疗效均为7－14d。结果：美罗培南组及亚胺培南－西司他丁组分别有42例及41例可评价疗效。两组有效率分别为88．1％（37／42）及85．4％（35／41）。对各种致病菌感染有效率分别为85．3％（29／34）和82．4％（28／34）。两组治疗前分离株分别为37株及38株。治疗后细菌清除率分别为81．1％（30／37）和84．2％（32／38）。两组安全性评价分别为44例及41例，不良反应发生率分别为13．6％（6／44）与12．2％（5／41）。两组经统计学处理差异无显著性（P＞0．05）。结论：美罗培南治疗急性细菌性感染疗效好，较安全。

A randomized, controlled clinical trial of meropenem and imipenem/cilastatin in the treatment of acute bacterial infections

OBJECTIVE: Meropenem is a new carbapenem antibiotic developed by Sumitomo Pharmaceuticals and shown to resist degradation by renal dehydropeptidase I (DPH-I), an enzyme which exists chiefly in the kidneys and decomposes carbapenem antibiotics. It has a powerful antibacterial activity with broad antibacterial spectrum. The objective of the study is to evaluate the efficacy and safety of meropenem. METHODS: A randomized, open-label, controlled study was conducted for treating patients with bacterial infections. A total of 112 hospitalized patients were enrolled in the study. 55 patients received meropenem 500 mg every 12 hours (or 1g every 12 hours if necessary) and 57 patients received imipenem/cilastatin 500 mg/500 mg every 12 hours (or 1g/1g every 12 hours if necessary) intravenously. The duration of treatment was 7-14 days in both groups. RESULTS: 42 of the 55 cases receiving meropenem and 41 of the 57 cases receiving imipenem/cilastatin were assessable for clinical efficacy. The overall efficacy rate was 88.1%(37/42) for the meropenem group and 85.4%(35/41) for the imipenem/cilastatin group, whereas the bacterial eradication rate was 81.1%(30/37) and 84.2%(32/38), respectively. 47(69.1%) of 68 strains isolated from patients produced beta-lactamase. Adverse drug reaction was evaluated in 44 cases of the meropenem group and 41 cases of the imipenem/cilastatin group. The adverse drug reaction rate was 13.6%(6/44) and 12.2%(5/41), respectively. The results showed that there were no statistical differences between these two groups (P > 0.05). CONCLUSION: Meropenem and imipenem/cilastatin were effective and safe for the treatment of lower respiratory tract infections and urinary tract infections and other infections caused by beta-lactamase-producing strains.